BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1221247 · Received November 5, 2008

    Report

    Report Number
    2029203-2008-00871
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    2029203-09/19/08-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REPORT OF A BURN WHILE CHARGING WAS REC'D. THE PT SAID HE REC'D REDNESS AT THE IMPLANT SITE WHEN HE SLEPT WHILE CHARGING. NO TREATMENT WAS PROVIDED, BUT THE SITE CONTINUES TO ITCH. PROD LABELING INSTRUCT THE PT NOT TO CHARGE WHILE SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP. SC-5300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention